Medical Writing & Scientific Publications Manager

We have a new and exciting pharmaceutical career opportunity for a Medical Writing & Scientific Publications Manager to work within a rapidly expanding pharma company that specialises in the research and development of treatments for areas that have unmet medical need. This job will be based at their UK site in Cambridge.

The Scientific Publications & Medical Writing team aims to provide effective and structured communication of the company scientific contents via publications as well as Medical Writing Services.

The Manager of Scientific Publications & Medical Writing works across international and multi-therapeutic areas to develop and deliver publication plans, write and/or edit or overseeing the writing of regulatory documents, scientific manuscripts, or other materials in support of R&D activities and goals. Activities include; the development or overseeing of outsourcing activities of Publication Plans and Strategies, Clinical Study Reports (Phase I-IV); Clinical Summary Documents, Investigator Brochures, sections of Marketing Authorisation Applications, non-dossier documents and publications (manuscripts, abstracts and posters) and Medical Writing input into other documents and activities as required.

Job Responsibilties:

• Management of the Scientific Publications & Medical Writing Team; providing expert advice and support to team members as well was guiding and coaching to resolve complex issues. Recruit, develop, train and manage Medical Writers & Scientific Publications Managers, ensuring their work is undertaken according to Eu-SOPs and company processes.
• Responsible for setting the strategic direction for the function in cooperation with the Director of Clinical Operations and directorate heads to ensure that the team meets the requirements of the business and is fit for the future
• Responsible to manage the resource and support requests by the business and providing support to functions within the company as well as to the independent associated companies as required via internal resources or via agencies and freelancers.
• Responsible for developing and improving the skills of each member of the Scientific Publications & Medical Writing Team making sure that the required skill and knowledge levels are obtained to full-fill the respective roles
• Responsible for constantly implementing and fulfilling the department aims
• Making sure that the responsible team members lead and deliver the project-specific publication planning and management in cooperation with the project teams on time and on budget.
• Ensuring that the agreed medical writing services are being delivered accurately and in high quality according to established timelines, working in close collaboration with clinical, scientific and regulatory colleagues.
• Leading the team to establish contacts and build business relationships with journals and agencies to expand the pool of contacts to be used for various publication projects
• Responsible for providing updates or guiding team members when giving updates on the scientific background of the development projects to all employees (e.g. induction programme, Town Hall Meetings, Joint R&D Get Togethers, magazine)

Skills and Requirements:

• Graduate training, or equivalent (at a minimum) in a bio-scientific discipline and excellent writing and project management skills. Requirements include a knowledge of biostatistics and an extensive background and familiarity with scientific literature.
• Requires demonstrable relevant experience in pharma or a medical communication agency to demonstrate a depth and breadth of Medical Writing and Publication Planning and Development proficiency and experience as appropriate for the level of the position.
• Working knowledge of Microsoft Office (Word, Excel, PowerPoint, Outlook) and other office or project programs such as Datavision, as appropriate.
• Experience with outsourcing processes and vendor management.
• CMPP or EMWA qualifications
• The variability of assignments requires flexibility and adaptability to the requirements of each.
• Ability to select, evaluate, analyse, interpret and apply logical integration of relevant scientific information and the ability to acquire such data.
• Ability to work independently and as part of a cross-functional team as well as leading others in a matrix environment.
• Ability to produce and oversee the development of comprehensible, valid, accurate and organised documents is essential.
• Insight, critical and analytical abilities and an ability to produce accurate high-quality work.
• Good interpersonal skills; ability to work independently and in global, multi-disciplinary teams is essential.
• Project management ability and strategic thinking.
• Leadership skills: coaching, mentoring and motivating.
• Excellent problem-solving ability, in order to provide innovative solutions to complex problems.
• Understanding the impact of aspects of the medical writing and scientific publications on the rest of the organisation.
• Understanding the principals of pharmaceutical drug development incl. regulatory requirements, clinical trial design and clinical development processes.
• An understanding of the decision-making processes within the International Associate Group of companies
• Working in compliance with existing SOPs.
• Excellent written English.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Tom Russell on +44 203 8246 104 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.